Clinical Trial Results:
A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (0.5 mg 17b-estradiol [E2] / 0.25 mg drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with 0.5 mg E2 / 0.25 mg DRSP with the bleeding pattern of subjects treated with 1.0 mg E2 / 0.5 mg norethisterone acetate (NETA) when used for hormone therapy (HT) for 1 year in post-menopausal women
Summary
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EudraCT number |
2006-006199-39 |
Trial protocol |
DK AT IT |
Global completion date |
17 Aug 2009
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Jul 2016
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First version publication date |
07 Dec 2014
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Other versions |
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Summary report(s) |
Bayer Study Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.